NCT06144151

A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.

Detailed description

Primary Objective: To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion. Secondary Objective: To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings Exploratory Objective: To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.

Conditions

• Neurotoxicity

Interventions

Type	Name	Description
DEVICE	NeurOptics® NPi®-300 Pupillometer	The pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes.

Timeline

• Start date: 2024-02-08
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2023-11-22
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study